Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GAM 2025-12-16

TroClose 1200

Applicant Gordian Surgical, Ltd.

K-Number K253620

View Details →

LJS 2025-12-16

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

Applicant Spectrum Vascular

K-Number K252373

View Details →

PPW 2025-12-16

prolaio eVO2peak Module (Version 1.0)

Applicant Prolaio, Inc.

K-Number K252204

View Details →

QPC 2025-12-16

VR® Personal Protective Level 3 Gown (VR Gowns)

Applicant PolyConversions, Inc.

K-Number K252940

View Details →

CAW 2025-12-16

V series portable oxygen concentrator (V5, V5C, V6, V6C)

Applicant Shenzhen Harveymed Technology Co., Ltd.

K-Number K252268

View Details →

FGB 2025-12-16

Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)

Applicant Guangzhou Red Pine Medical Instrument Co., Ltd.

K-Number K251951

View Details →

FGB 2025-12-16

Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)

Applicant Zhejiang Geyi Medical Instrument Co., Ltd.

K-Number K252468

View Details →

QIH 2025-12-16

IRISeg

Applicant Intuitive Surgical, Inc.

K-Number K251763

View Details →

OWB 2025-12-16

SKAN C PULSAR

Applicant Skanray Technologies Limited

K-Number K251893

View Details →

OVK 2025-12-16

ADVIA Centaur Cytokeratin Fragment 21-1

Applicant Fujirebio Diagnostics,Inc.

K-Number K250925

View Details →

BZD 2025-12-15

SleepRes PAP System

Applicant Sleepres, Inc.

K-Number K251770

View Details →

LKF 2025-12-15

FemVue® Controlled Saline-Air Device (FSA-300)

Applicant Femasys, Inc.

K-Number K253403

View Details →

Page 116 of 2685

↑